Course Information
Course Semester Plan
Course Information
| No | Module name | Development and Characteristics of Raw Materials and Pharmaceutical Excipients |
| 1 | Courses code | P20.02010 |
| 2 | Study loads | 2 credits |
| 3 | Semester | Second Semester |
| 4 | Precondition | there is no |
| 5 | Competence | Upon completion of this course, students are expected to be able to: 1. State the physicochemical properties of medicinal raw materials and excipients 2. Explain the terms in Indonesia Pharmacopeia, USP, WHO and other pharmacopeias 3. State the importance of basic knowledge in the development of medicinal raw materials and excipients 4. State, define and identify physicochemical properties of medicinal raw materials and excipients in safety and stability requirements. |
| 6 | Elements of competency | MKK |
| 7 | Type competency | supporting competence |
| 8 | Syllabus | 1. Drug Discovery and Development; 2. Pre-formulation Study; 3. Active Pharmaceutical Ingredients; 4. Pharmaceutical Excipients; 5. Pre-formulation Criteria; 6. Drug dosage forms consideration in formulation; 7. Early Drug Development: Product Design; 8. Mid- term exam; 9. Discovery of medicinal raw materials, active pharmaceutical ingredients (API); 10. Processing of medicinal raw materials, API; 11. Independent Development of medicinal raw materials, API; 12. Development of medicinal raw materials, API; 13-15 Development of medicinal raw materials, API in pharmaceutical dosage forms: Solid and semisolid, Liquid and pareneteral, Ophthalmic and other preparations; 16. Final Exam |
| 9 | Attribute to soft skills | Creativity in discussions, making resumes, presentations, discipline in submitting assignments, presentations, class participation, etc |
| 10 | Learning methods | Active learning: Presentation, Case Study |
| 11 | Learning media | the LCD viewer, laptop, white board and “online” (Google Meet) |
| 12 | Appraisal | Written test: Individual task 10%; Mid-term Exam 30%, Final Exam 40%, Soft Skill 20% |
| 13 | Lecturer | Prof. Dr. apt. Marline Abdassah, MS (PIC) Dr.apt. Dolih Gozali, MS. |
| 14 | References | Stanley Nusim, 2016, Active Pharmaceutical Ingredients Development, Manufacturing, and Regulation, Second Edition, Publisher: CRC Press; Anthony J. Burke, Carolina Silva Marques, Nicholas J. Turner , Gesine J. Hermann, 2018, Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development 1st Ed., Publisher: Wiley. David J. AM Ende Mary T. AM ENDE, 2019, Chemical Engineering in Therapeutical Industry, Active Pharmaceutical Ingredients, Second Edition, Edited Engineering Services, Inc. Augsburger LL, Zellhofer MJ., 2006, Tablet formulation. In: Swarbrick J, Boylan JC, editors. Encyclopedia of pharmaceutical technology. 3rd ed. New York: Marcel Dekker. Martindale: The complete drug reference. 37th ed. London: Pharmaceutical Press; 2011. (electronic and hard copy available) International Excipients Certification Project: minimize risks – maximize benefits. 2009, London: Pharmaceutical Quality Group. Armstrong NA. Tablet manufacture. In: Swarbrick J, Boylan JC, editors. Encyclopedia of pharmaceutical technology. 3rd ed. New York: Marcel Dekker; 2006. |
Course Semester Plan